Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: ABT-333 Tablet; Drug: ABT-333 Capsule; Drug: Placebo

• Registration Number: NCT00895102
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2009-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• overall healthy subjects;
• non-childbearing potential females included

Exclusion Criteria

• history of significant sensitivity to any drug;
• positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
• history of gastrointestinal issues or procedures;
• history of seizures, diabetes or cancer (except basal cell carcinoma);
• clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
• use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
• donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
• abnormal screening laboratory results that are considered clinically significant by the investigator;
• current enrollment in another clinical study;
• previous enrollment in this study;
• recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
• pregnant or breastfeeding female;
• requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. ABT-333 Capsule vs ABT-333 Tablet	ABT-333 Tablet	400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
1. ABT-333 Capsule vs ABT-333 Tablet	ABT-333 Capsule	400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
2. ABT-333 Tablet	ABT-333 Tablet	ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)
2. ABT-333 Tablet	Placebo	ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)
3. Placebo	ABT-333 Tablet	Placebo tablets, QD, single ascending doses
3. Placebo	Placebo	Placebo tablets, QD, single ascending doses

Primary Outcome Measures

Name	Time	Method
To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation	2 days post dosing
To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo	2 days post dosing
To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation	2 days post dosing
Pharmacokinetics	5 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 19441; 🇺🇸 Waukegan, Illinois, United States